Duns Number:125111448
Device Description: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
Catalog Number
-
Brand Name
AMS 700 CX MS Pump
Version/Model Number
72404235
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JCW
Product Code Name
Prosthesis, Penis, Inflatable
Public Device Record Key
279afce3-3f8c-43ff-8a0b-e96de289b56e
Public Version Date
February 13, 2019
Public Version Number
4
DI Record Publish Date
September 25, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 139 |